Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD) currently applies to Covid-19 tests. In order to place this type of tests on the EU market, compliance with the relevant provisions of the Directive is necessary (European Commission, 2020).
Special attention needs to be paid when Covid-19 tests include swabs as part of the kit. While the kit itself will follow the IVDD compliance route, the swab is a Class I medical device that must also bear a CE mark and meet certain requirements. Particularly, the swab must follow the provisions of Directive 93/42/EEC of 14 June 1993 and Regulation 2017/745 of 5 April 2017 on medical devices (FAMPH, 2020).
The Belgian Federal Agency for Medicines and Health products has recently shed light on the specifications and documents the manufacturers of this type of kits need to provide in order to prove compliance for the swab.
Firstly, when a swab is present in an Covid-19 test kit, the following information must appear on the packaging of the product:
- Name and address of the swab manufacturer next to the following symbol
- Name and address of their European Authorised Representative if the swab manufacturer is based outside the European Union next to the following symbol
- Name of the swab
- CE marking
- If the swab is sterile:
– the symbol for the method used to make the device sterile
or
or just the word “sterile”;
– the four digits of the swab’s Notified Body (FAMPH, 2020).
To conclude, manufacturers, as well as the European Authorized Representative, will need to pay closer attention when dealing with this type of kits and their specifications, in order to ensure full compliance with the concerned provisions.
Bianca Sofian
VIP Department
04/03/2021
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References:
- European Commission (2020). Communication from The Commission – Guidelines on COVID-19 in vitro diagnostic tests and their performance, p. 1. Retrieved on 04/03/2021 from https://ec.europa.eu/info/sites/info/files/testing_kits_communication.pdf
- FAMPH (2020). Coronavirus: swabs: compliance verification. Retrieved on 04/03/2021 from https://www.famhp.be/en/news/coronavirus_swabs_compliance_verification